AXSANA

The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.

{ "short_title": "AXSANA", "data_mode": "900", "data_mode_number": "000002165", "official_title": "A Prospective Multicenter Cohort Study to Evaluate Different Surgical Methods of Axillary Staging (Sentinel Lymph Node Biopsy, Targeted Axillary Dissection, Axillary Dissection) in Clinically Node-positive Breast Cancer Patients Treated With Neoadjuvant Chemotherapy", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "not_applicable", "ctgov_number": "NCT04373655", "eudract_number": null, "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Dr. med. Cornelia Meisel", "description_laie_de": "Prospektive, multizentrische Registerstudie zur Bewertung verschiedener \r\nleitlinienkonformer Operationsverfahren in der Axilla (Sentinel-Node Biopsie, \r\nTargeted Axillary Dissection, Axilladissektion) nach neoadjuvanter Chemotherapie", "description_laie_en": "Prospective, multicenter registry study to evaluate various guideline-compliant surgical procedures in the axilla (sentinel node biopsy, targeted axillary dissection, axillary dissection) after neoadjuvant chemotherapy", "description_expert_de": "Prospektive, multizentrische Registerstudie zur Bewertung verschiedener \r\nleitlinienkonformer Operationsverfahren in der Axilla (Sentinel-Node Biopsie, \r\nTargeted Axillary Dissection, Axilladissektion) nach neoadjuvanter Chemotherapie", "description_expert_en": "The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 3, "sub_cat_id": 16 }